Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Implementation of the Guideline

Description of Implementation Strategy

Dissemination and Implementation

These guidelines are widely disseminated through the CHEST journal publication, National Guideline Clearinghouse, and Guidelines International Network library. Additional clinical resources will soon be available to users of CHEST Evidence, an upcoming tool for searching the content of America College of Chest Physicians (ACCP) guidelines.

As the expanding research into diagnostic techniques and treatment options continues to evolve, the guidelines must be updated and kept current. This edition of the ACCP Lung Cancer Guidelines will be the last to be published as a complete collection, as the ACCP is now embarking on a new living guidelines model (LGM) for revising existing recommendations and developing new recommendations as the literature evolves. This will include a continual assessment of the currency of these recommendations relevant to new research studies as they are published. The review cycle for the ACCP Lung Cancer Guidelines will begin 1 year after publication unless the content experts who monitor the literature bring a recommendation or set of related recommendations to the attention of the Guideline oversight Committee (GOC), suggesting that those recommendations are in need of updating sooner. The new LGM will permit a more nimble approach to guideline development but also requires a point-of-care accessible vehicle, CHEST Evidence, for the users to readily search for the most current version. These features will be described in greater detail in upcoming publications. As a step in this direction, these guidelines will be published primarily online with a printed version of the Executive Summary, containing all of the recommendations, the introduction, and this article on methodology. All narratives for each article with their supporting tables, figures, and algorithms will be available online at journal.publications.chestnet.org.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate establishment of the diagnosis of lung cancer

Potential Harms

False-positive and false-negative results of diagnostic tests

Data on complications after transthoracic needle aspiration (TTNA) are limited to case series from selected institutions. A cross-sectional analysis of 15,865 adults who had undergone TTNA was performed to determine the risks of complication after TTNA of a pulmonary nodule. Hemorrhage complicated only 1% (95% confidence interval [CI], 0.9%–1.2%) of biopsies, but of these, 18% (95% CI, 12%–24%) required a blood transfusion. In contrast, the risk of any pneumothorax was 15% (95% CI, 14%–16%), and 7% (95% CI, 6%–7.2%) of all biopsies resulted in pneumothorax requiring a chest tube.

Recommendation can apply to most patients in most circumstances. Further research is very unlikely to change confidence in the estimate of effect

Strong recommendation, moderate-quality evidence, Grade 1B

Benefits clearly outweigh risk and burdens or vice versa

Evidence from RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise), or very strong evidence from observational studies

Recommendation can apply to most patients in most circumstances. Higher quality research may well have an important impact on confidence in the estimate of effect and may change the estimate

Strong recommendation, low- or very-low-quality evidence, Grade 1C

Benefits clearly outweigh risk and burdens or vice versa

Evidence for at least one critical outcome from observational studies, case series, or from RCTs with serious flaws or indirect evidence

Recommendation can apply to most patients in many circumstances. Higher-quality research is likely to have an important impact on confidence in the estimate of effect and may well change the estimate

Weak recommendation, high-quality evidence, Grade 2A

Benefits closely balanced with risks and burden

Consistent evidence from RCTs without important limitations or exceptionally strong evidence from observational studies

The best action may differ depending on circumstances or patient's or societal values. Further research is very unlikely to change confidence in the estimate of effect

Weak recommendation, moderate-quality evidence, Grade 2B

Benefits closely balanced with risks and burden

Evidence from RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise) or very strong evidence from observational studies

Best action may differ depending on circumstances or patient's or societal values. Higher-quality research may well have an important impact on confidence in the estimate of effect and may change the estimate

Weak recommendation, low- or very-low-quality evidence, Grade 2C

Uncertainty in the estimates of benefits, risks, and burden; benefits, risk, and burden may be closely balanced

Evidence for at least one critical outcome from observational studies, case series, or RCTs, with serious flaws or indirect evidence

Other alternatives may be equally reasonable. Higher-quality research is likely to have an important impact on confidence in the estimate of effect and may well change the estimate

Qualifying Statements

Qualifying Statements

American College of Chest Physicians (ACCP) guidelines are intended for general information only, are not medical advice, and do not replace professional medical care and physician advice, which always should be sought for any medical condition. The complete disclaimer for this guideline can be accessed at the CHEST Web site.

Although the ACCP is moving toward the production of evidence profiles for all guideline recommendations, there were many recommendations for which profiles were not developed, mostly because of resource constraints. When possible, methodologists created evidence profiles, and all panelists were educated on how to read and interpret them. The population, intervention, comparator, and outcome (PICO)-based systematic literature review process was followed for most recommendations, but there were some that could have benefited from meta-analyses.

One limitation of all guidelines today is that they are not able to adequately address complex patients with multiple morbidities. This is largely because these patients are generally excluded from clinical trials and are often not included in observational studies. Since guidelines are reliant on evidence published in the peer-reviewed literature, the scientific foundation impedes the process of providing good guidance for these patients and is a limitation in these guidelines. Therefore, the ACCP encourages funding agencies to ensure that topics with limited evidence are addressed in future research.

Methodology

Methods Used to Collect/Select the Evidence

Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

In collaboration with an American College of Chest Physicians (ACCP) methodologist, the writing committee carried out a systematic search of the MEDLINE, Healthstar, and Cochrane Library databases, covering July 2004 (to overlap with the search for the second edition of the guidelines) to July 2011. The searches were limited to English-language and human studies of at least 50 patients with suspected lung cancer, and only studies that provided information on test parameters with an adequate definition of final true results were included (i.e., histologic confirmation or radiographic follow-up of at least 1 year). Both prospective and retrospective studies were included; because of the nature of the subject (diagnostic test), randomized studies were generally not appropriate or were unavailable. Details of the searches for the specific topics are described in the particular section; full details of the searches are available from the ACCP upon request.

To structure the literature search, the following patient, intervention, comparison, outcomes (PICO) questions were selected as the most relevant (see Table S1 in the supporting data [see the "Availability of Companion Documents" field]):

How do the test performances of closed, image-guided pleural biopsy and thoracoscopic pleural biopsy compare for evaluating pleural effusions for malignancy in patients with known or suspected lung cancer?

What are the performance characteristics of sputum cytology for the diagnosis of lung cancer, with special consideration for the location of the tumor?

What are the performance characteristics of flexible bronchoscopy (FB) and its ancillary procedures for the diagnosis of central (endobronchial) as opposed to peripheral tumors and peripheral tumors <2 and >2 cm in size?

What are the performance characteristics of radial endobronchial ultrasound (R-EBUS) as a diagnostic modality for peripheral lung cancer?

What are the performance characteristics of electromagnetic navigation (EMN) in the diagnosis of a peripheral lung lesion (PLL)?

What are the performance characteristics of transthoracic needle aspiration (TTNA) as a diagnostic modality, with particular emphasis on the size and location of the suspected cancer?

What is the diagnostic error when differentiating between non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) generated by various diagnostic techniques (bronchoscopy, TTNA, and sputum cytology)?

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Not Given)

Rating Scheme for the Strength of the Evidence

Not stated

Methods Used to Analyze the Evidence

Review of Published Meta-Analyses Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

Assessment of Study Quality

Systematic reviews and meta-analyses were assessed using Documentation and Appraisal Review Tool (DART) (R. L. Diekemper; B. K. Ireland, MD; and L. R. Merz, PhD, MPH, DART, unpublished data, 2012), which was developed as an improved alternative to the existing tools for use in a clinical setting. However, this tool has been adopted for use in American College of Chest Physicians (ACCP) guidelines and consensus statements since 2011.

Quality was assessed for each study as well as for the body of relevant evidence. Based on the population, intervention, comparator, and outcome (PICO) questions and volume of available literature, multiple study designs were included in the systematic reviews of the literature. Randomized controlled trials (RCTs) primarily indicate benefits, but whenever observational studies met inclusion criteria they were often helpful in identifying harms. Observational studies were also examined when RCTs were not available to answer a particular PICO question. Allowing for multiple study designs resulted in the need for multiple quality assessment tools. Tools were chosen for assessing RCTs, observational studies, and diagnostic studies. The quality assessment tool for RCTs (R. L. Diekemper, B. K. Ireland, and L. R. Merz, unpublished data, 2012) was used for assessing the quality of RCTs, and a tool developed by the committee of the ninth edition of the Antithrombotics Guidelines was used for assessing the quality of observational studies. Diagnostic studies were assessed using the Quality Assessment Tool for Diagnostic Accuracy Studies (QUADAS).

Meta-analyses

If a recently published good-quality meta-analysis was available, then it was used to inform the recommendations. When a good-quality meta-analysis was not available, guideline authors were encouraged to perform their own meta-analyses. Meta-analyses were performed when the data were fairly homogeneous. If a study was deemed poor quality, then it was not included in the pooled analysis. Heterogeneity of the pooled results was assessed using a χ2 test and Higgins I2, and a forest plot was examined for consistency of the results. The random effects model was chosen a priori as the appropriate model for pooling the data because it accounts for heterogeneity among the included studies. Results from the meta-analyses are available in the supplementary materials that can be downloaded from the Journal website under the corresponding article in the table of contents.

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Panel Composition and Responsibilities

A call for applications to serve on the 3rd edition of the American College of Chest Physicians (ACCP) Lung Cancer Guidelines (LC III) panel was put forth to the ACCP membership, to past panelists, and to other organizations that have previously endorsed earlier editions of these guidelines or appointed representatives to serve on those panels. Guiding the team was the LC III Executive Committee, composed of a Panel Chair, Vice Chair, Liaison to the Guidelines Oversight Committee (GOC), and two staff members, one serving as an adviser and the other as the lead methodologist. The GOC appointed the Liaison and the Chair, who was required to be free of conflicts of interest (COI). This Executive Committee provided general oversight and guidance; multiple reviews of research questions, article outlines, manuscripts, evidence tables, and other supporting documents; and facilitation of the final conference discussions and voting. As the scope was defined, content experts in each major area were identified to serve as topic editors and nominated by the Panel Chair to be advanced to the GOC for the requisite qualifications and COI review and approval process. These topic editors organized their research and writing teams, oversaw the work of the individual members, edited separate contributions into synthesized manuscripts, presented evidence at the final conference, and managed any of their committee members who were approved with management stipulations relevant to their COIs.

Each topic editor was initially charged with proposing individuals to support their topic committees with expertise in the content area and/or methodology. With the Chair's approval, these individuals were nominated for GOC reviews for COI and expertise. In some cases, GOC staff helped to locate additional methodologic support when it was determined to be necessary for various article committees. This resulted in an international panel of >100 multidisciplinary experts across 24 articles representing the fields of pulmonary medicine, critical care medicine, thoracic surgery, medical and radiation oncology, pathology, integrative medicine, primary care, health-care research, guidelines methodology, and epidemiology. Nineteen international organizations that are also dedicated to advancing research and practice in the area of lung cancer were invited to appoint representatives to this guideline project as adjunct participants. These individuals, unless already approved panelists, were not considered full voting members of the panel, since they had not been through the same ACCP COI review, but were included at the final conference, participated fully in the discussions, and provided external review and feedback on the manuscripts and supporting documentation.

Formulating the Recommendations

In most cases the topic editors, along with the other completely non-conflicted members of the article committee, formulated the recommendations. The summarized evidence tables and profiles (where profiles existed) provided the foundation for the recommendations. In formulating the recommendations, panelists considered not only the body of evidence but also the balance between the benefits and harms and considerations of other factors, such as cost or resource availability considerations and patient values and preferences, which might vary widely for some recommendations. These additional considerations are described in a Remarks section, which appears just below the relevant recommendation in the publication, each time the recommendation appears.

Grading the Recommendations

Recommendations that are strong must be differentiated from those that are weak or weaker. Thus, the ACCP Grading System was used (see the "Rating Scheme for the Strength of the Recommendations" field), and the wording of the recommendations is explicit. This grading system has been used since 2005 and is based on two dimensions: the balance of benefits to harms and the quality of the evidence base. If the benefits clearly outweigh the harms or the harms clearly outweigh the benefits, the strength of the recommendation is considered strong and graded as a 1. In most cases, when there is strong confidence that the benefits outweigh the harms, most patients would choose the intervention endorsed in that recommendation. However, when the tradeoffs between desirable and undesirable consequences are not as clear, variability in patient preferences and values often becomes germane to the decision-making conversation.

Weak recommendations are those for which the benefits and harms are more equally balanced, and thus a clear choice is not as obvious; these are graded with a 2. Strong recommendations are phrased, "the panel recommends," whereas weak recommendations are phrased "the panel suggests." Accompanying these indications of the strength of a recommendation is a letter score (A, B, or C) representing the grading of the body of relevant literature.

In grading the quality of the evidence, RCTs start with a high score but might be downgraded to moderate or even low based on the following criteria: limitations in the study design or conduct of the trial, imprecision, indirectness relative to the specifics of the PICO question, inconsistency in the results, and risk of reporting bias. Observational studies, on the other hand, start off as low-level evidence but can be upgraded to moderate or even high if exceptionally large and consistent treatment effects increase confidence in the findings, especially if there is a strong dose-response gradient.

The final grades are combinations reflecting the strength of the recommendation and the quality of the evidence. Strong recommendations with high quality evidence, grade of 1A, are less common than in past editions of these guidelines, since the evidence is assessed with greater rigor for most topics, and few studies without important limitations are available.

However, recommendations that do attain this score are those for which the panel could state with confidence that new studies would be unlikely to change the direction of the effect. These recommendations apply to most patients in most circumstances. But as the grades decline, patient values and preferences likely would play an increasingly greater role in determining the best treatments or interventions for each patient.

The Final Conference

As the evidence reviews were completed and the tables and profiles prepared, the manuscripts and recommendations were drafted. Members of the article committees convened by phone or e-mail to discuss the evidence and work on drafting and grading the recommendations. These discussions generally resulted in agreement on both the quality of the evidence and strength of the recommendations.

The manuscripts and supporting tables were then reviewed by members of the Executive Committee and, after several iterations, the revised versions were shared among all panelists and the representatives of invited organizations in advance of the conference. The other panelists and representatives were asked not only to provide feedback but also to review the recommendations to identify any controversies. A recommendation was deemed to be controversial if at least one person disagreed with the wording or the grading, if there was controversy in practice, if there were wide variations in practice, or if at least one person asked that it be discussed among the broader panel and association representatives. These identified controversies composed the main agenda for the conference.

See the "Methodology for Development of Guidelines for Lung Cancer" (see the "Availability of Companion Document" field) for more information.

Cost Analysis

American College of Chest Physicians (ACCP) guidelines include consideration of resources in recommendations under selected circumstances. If it is likely that resource considerations would impact the direction or strength of a recommendation, a search for cost-effectiveness studies may have been conducted. Most recommendations in these guidelines do not include a full assessment of resource considerations. However, they can be adapted to middle- and low-income countries using the ADAPTE strategies.

Method of Guideline Validation

External Peer Review Internal Peer Review

Description of Method of Guideline Validation

Internal and External Peer Review

Once Executive Committee approval was received, the articles were submitted to American College of Chest Physicians (ACCP) staff for several layers of review. All reviewers were required to undergo a full conflict of interest (COI) appraisal before being approved. In the first round of reviews, the Thoracic Oncology NetWork reviewed the content of the manuscripts and the members of the Guidelines Oversight Committee (GOC) assessed the manuscripts for adherence to the methodology and conformance with the evidence. The ACCP President also appointed members of the Board of Regents to evaluate the guidelines in depth. All comments were collated into spreadsheets to ensure that they were appropriately answered. GOC and board reviewers discussed each comment and determined which should be mandatory for the authors to amend and which were provided as suggestions for improvement. All reviews and comments were anonymous, and authors were required to respond to all mandatory issues either by revising the manuscripts or providing written justification explaining why they did not agree with the reviewers' comments.

The revised manuscripts were submitted for round II review, simultaneously with the Journal peer review. Once the GOC and board reviewers approved the manuscripts, the ACCP President, President Elect, President Elect Designee, and Immediate Past President reviewed the guidelines. Approval was granted pending confirmation from the Board of Regents, before submission to the journal for final review by the Journal Editor. In addition to this extensive review process, which included nearly 30 individual reviewers from the ACCP leadership, external organizations were provided with opportunities to provide feedback before, during, and just after the conference. This final version was submitted for consideration for endorsement to all of the invited organizations, whether or not they sent representatives to the conference. However, once the guidelines were approved by the ACCP Board of Regents, no further changes were accepted. Organizations that provided endorsements are listed in each article.

The development of this guideline was supported primarily by the American College of Chest Physicians (ACCP). The lung cancer guidelines conference was supported in part by a grant from the Lung Cancer Research Foundation. The publication and dissemination of the guidelines was supported in part by a 2009 independent educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.

Role of sponsors: The ACCP was solely responsible for the development of these guidelines. The remaining supporters played no role in the development process. External supporting organizations cannot recommend panelists or topics, nor are they allowed prepublication access to the manuscripts and recommendations. Further details on the Conflict of Interest (COI) Policy are available online at http://chestnet.org.

See the methodology companion (see the "Availability of Companion Documents" field) for a complete discussion of the source of funding for this guideline.

Guideline Committee

American College of Chest Physicians (ACCP) Expert Panel on Lung Cancer Guidelines

Conflicts of Interest (COI) grids reflecting the conflicts of interest that were current as of the date of the conference and voting are posted in the online supplementary materials.

Financial/nonfinancial disclosures: Dr Rivera has served on an advisory board for Boehringer-Ingelheim. Dr Mehta has served as a consultant for superDimension, Inc. Dr Wahidi has received educational grants from Olympus America, Inc and Pentax, Inc. He has also served as a consultant with Olympus America, Inc and Veran Medical Technologies.

See the methodology companion (see the "Availability of Companion Documents" field) for a complete discussion of the conflict of interest procedures and requirements for the guideline panel.

Understanding non-small cell lung cancer. A guide for the patient. Northbrook (IL): American College of Chest Physicians; 2010. 13 p. Electronic copies: Available in PDF from the OneBreath.org Web site.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI on July 22, 2003. The information was verified by the guideline developer on August 18, 2003. This NGC summary was updated by ECRI Institute on November 8, 2007. The updated information was verified by the guideline developer on December 21, 2007. This NGC summary was updated by ECRI Institute on August 21, 2013.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

To inform the clinical decisions that must be jointly made by physicians and patients in developing diagnostic, treatment, and management plans so that they can enhance the benefits and reduce the harms associated with various options

To determine the test performance characteristics of various modalities for the diagnosis of suspected lung cancer

To update previous recommendations on techniques available for the initial diagnosis of lung cancer

Target Population

Patients with suspected lung cancer

Interventions and Practices Considered

Sputum cytology

Thoracentesis

Fine needle aspiration (FNA)

Bronchoscopy including transbronchial needle aspiration (TBNA)

Endobronchial ultrasound–needle aspiration (EBUS-NA)

Endoscopic ultrasound-guided needle aspiration (EUS-NA)

Transthoracic needle aspiration (TTNA)

Mediastinoscopy

Pleural biopsy

Computed tomography (CT)

Electromagnetic navigation guidance

Major Outcomes Considered

Sensitivity and specificity of diagnostic tests

Accuracy of diagnostic modalities (diagnostic error rate)

Recommendations

Major Recommendations

The grades of recommendation (1A–2C) and the approach to rating the quality of evidence are defined at the end of the "Major Recommendations" field.

Diagnosis of Pleural Abnormalities

In patients suspected of having small cell lung cancer (SCLC) based on the radiographic and clinical findings, it is recommended that the diagnosis be confirmed by the least invasive method (sputum cytology, thoracentesis, fine needle aspiration [FNA], bronchoscopy including transbronchial needle aspiration [TBNA]), as dictated by the patient's presentation (Grade 1C).

In patients suspected of having lung cancer, who have extensive infiltration of the mediastinum based on radiographic studies and no evidence of extrathoracic metastatic disease (negative positron emission tomography [PET] scan), it is recommended that the diagnosis of lung cancer be established by the least invasive and safest method (bronchoscopy with TBNA, endobronchial ultrasound-guided needle aspiration [EBUS-NA], endoscopic ultrasound-guided needle aspiration [EUS-NA], transthoracic needle aspiration [TTNA], or mediastinoscopy) (Grade 1C).

In patients suspected of having lung cancer who have a solitary extrathoracic site suspicious of a metastasis, it is recommended that tissue confirmation of the metastatic site be obtained if a FNA or biopsy of the site is feasible (Grade 1C).

In patients suspected of having lung cancer, who have lesions in multiple distant sites suspected of metastases but in whom biopsy of a metastatic site would be technically difficult, it is recommended that diagnosis of the primary lung lesion be obtained by the least invasive method (Grade 1C).

In patients suspected of having lung cancer who have an accessible pleural effusion, thoracentesis is recommended to diagnose the cause of the pleural effusion (Grade 1C).

Remark: Ultrasound-guided thoracentesis improves the success rate and decreases the rate of pneumothorax and therefore ultrasound is recommended for performing diagnostic thoracentesis.

In patients suspected of having lung cancer who have an accessible pleural effusion, if pleural fluid cytology is negative, pleural biopsy (via image-guided pleural biopsy, medical or surgical thoracoscopy) is recommended as the next step (Grade 1C).

Remark: If the computed tomography (CT) scan of the chest shows pleural thickening or pleural nodules/masses, image-guided needle biopsy may be considered as the first step to obtain a biopsy of the pleura.

Remark: If pleural cytology is negative after the first thoracentesis, a second thoracentesis has been shown to increase the diagnostic yield of pleural fluid cytology. Depending on preferences and values (a simpler and less invasive test vs a more definitive test) a second thoracentesis may be considered before proceeding to biopsy of the pleura.

Diagnosis of Primary Tumor

Sputum Cytology

In patients suspected of having lung cancer, if sputum cytology is done but is negative for carcinoma, it is recommended that further testing be performed (Grade 1C).

Remark: Sputum cytology is an acceptable method of establishing the diagnosis. However, the sensitivity or sputum cytology varies by location of the lung cancer, and with the frequency and processing of the sputum at each individual center.

Flexible Bronchoscopy

In patients suspected of having lung cancer, who have a central lesion, bronchoscopy is recommended to confirm the diagnosis. However, it is recommended that further testing be performed if bronchoscopy results are non-diagnostic and suspicion of lung cancer remains (Grade 1B).

Remark: In recent years a number of complementary tools including radial endobronchial ultrasound (R-EBUS) and electromagnetic navigation have been added to flexible bronchoscopy to aid in the diagnosis of peripheral lung lesions.

R-EBUS

In patients suspected of having lung cancer, who have a peripheral lung nodule, and a tissue diagnosis is required due to uncertainty of diagnosis or poor surgical candidacy, radial EBUS is recommended as an adjunct imaging modality (Grade 1C).

Remark: Radial EBUS can confirm in real time the ideal location of bronchoscopic sampling and increase the diagnostic yield over conventional bronchoscopy for peripheral nodules.

Electromagnetic Navigation

In patients with peripheral lung lesions difficult to reach with conventional bronchoscopy, electromagnetic navigation guidance is recommended if the equipment and the expertise are available (Grade 1C).

Remark: The procedure can be performed with or without fluoroscopic guidance and it has been found complementary to radial probe ultrasound.

Remark: If electromagnetic navigation is not available, TTNA is recommended.

Transthoracic Needle Aspiration

In patients suspected of having lung cancer who have a peripheral lesion, and who require tissue diagnosis before further management can be planned, TTNA is diagnostic option. However, it is recommended that further testing be performed if TTNA results are non-diagnostic and suspicion of lung cancer remains (Grade 1B).

Cell Type Accuracy

In patients suspected of having lung cancer, the diagnosis of non-small cell lung cancer made on cytology (sputum, TTNA, bronchoscopic specimens, or pleural fluid) is reliable. However, it is recommended that adequate tissue be obtained to accurately define the histologic type and to perform molecular analysis when applicable (Grade 1B).

Remark: It is critical to obtain adequate tissue to characterize a lung cancer. Within an institution, effective communication between those obtaining the biopsies, those interpreting them, and those delivering the treatment must be in place so that collectively, the members of varying subspecialties involved in the care of the lung cancer patient can decide how best to obtain and optimally use the tissue. If specimens are not adequate for histologic and molecular characterization then obtaining a second biopsy is acceptable given the importance of accurate tumor characterization.

The possibility of an erroneous diagnosis of SCLC on a cytology specimen must be kept in mind if the clinical presentation or clinical course is not consistent with that of SCLC. In such a case, it is recommended that further testing be performed to establish a definitive cell type (Grade 1B).

Recommendation can apply to most patients in most circumstances. Further research is very unlikely to change confidence in the estimate of effect

Strong recommendation, moderate-quality evidence, Grade 1B

Benefits clearly outweigh risk and burdens or vice versa

Evidence from RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise), or very strong evidence from observational studies

Recommendation can apply to most patients in most circumstances. Higher quality research may well have an important impact on confidence in the estimate of effect and may change the estimate

Strong recommendation, low- or very-low-quality evidence, Grade 1C

Benefits clearly outweigh risk and burdens or vice versa

Evidence for at least one critical outcome from observational studies, case series, or from RCTs with serious flaws or indirect evidence

Recommendation can apply to most patients in many circumstances. Higher-quality research is likely to have an important impact on confidence in the estimate of effect and may well change the estimate

Weak recommendation, high-quality evidence, Grade 2A

Benefits closely balanced with risks and burden

Consistent evidence from RCTs without important limitations or exceptionally strong evidence from observational studies

The best action may differ depending on circumstances or patient's or societal values. Further research is very unlikely to change confidence in the estimate of effect

Weak recommendation, moderate-quality evidence, Grade 2B

Benefits closely balanced with risks and burden

Evidence from RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise) or very strong evidence from observational studies

Best action may differ depending on circumstances or patient's or societal values. Higher-quality research may well have an important impact on confidence in the estimate of effect and may change the estimate

Weak recommendation, low- or very-low-quality evidence, Grade 2C

Uncertainty in the estimates of benefits, risks, and burden; benefits, risk, and burden may be closely balanced

Evidence for at least one critical outcome from observational studies, case series, or RCTs, with serious flaws or indirect evidence

Other alternatives may be equally reasonable. Higher-quality research is likely to have an important impact on confidence in the estimate of effect and may well change the estimate

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NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

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